FDA approves generic for Tecfidera - what this could mean to you.

When a branded drug, such as Tecfidera, loses or outgrows its patent, then a generic may become available.  And this may be an expensive change depending on the state you live in.  

On August 17, 2020, the FDA approved a generic drug of dimethyl fumarate by maker, Mylan (now part of Viatris), that is biosimilar to Biogin’s branded Tecfidera. This is VERY important to know in certain states such as California because your insurance may no longer cover brand name Tecfidera starting Jan 2021.  Or the pharmaceutical company may no longer be able to provide financial assistance.  Your doctor may need to change your script before the end of the year.

It’s very important that you talk with your doctor and your insurance company.  

Not all states prohibit/limit copay/financial assistance.  The generic dimethyl fumarate is made by Mylan with unclear copay assistance.  If you want brand-name Tecfidera, ask your doc to write Dispense as Written DAW on script. Pharmacy wouldn’t be able to substitute with generic. Insurance company may or may not cover brand-name med.

Each state is different.  Taken from RollCall - News from Congress

  • “In Arizona, a new law bans insurers from excluding the discounts only when a brand-name drug lacks a generic alternative, or if the patient obtains permission from his or her insurer to use the branded version.
  • A 2017 California law prohibits manufacturers from offering coupons at all if a generic is available, but allows copay assistance from independently controlled charities.
  • A 2012 Massachusetts law prohibits drug manufacturers from offering coupons or other assistance when a generic is available. The generic provision is scheduled to sunset soon, so coupons would be outlawed entirely.
  • A bill in New Hampshire follows California’s law, and also grants an exemption to patients who obtained their plan’s permission for the branded drug.
  • A New Jersey bill would outlaw discounts from drug manufacturers but doesn’t mention charities.“

Each state in this country is different but here in California, there is a law (AB265) that prohibits pharmaceutical companies from providing financial assistance for their drugs to their patients once a generic is approved. 

I’m not here to form an opinion rather than to inform you that if you live in a state like California and your insurance can not cover Tecfidera or you rely on financial assistance from Biogen, then you could end up with a giant copay surprise.  Check with your insurance, state and your neurologist. My neurologist was the one who told me about this and I’m not on it. But this is so important to know!  

He mentioned how  important It is to talk with these people and make necessary changes prior to the beginning of the year, 2021, as that’s when the insurance coverage will change for this drug.  

Talk with your HCP. Talk with your Insurance Company.  Call Biogen Support Services ( 1-800-456-2255).  

Biogen is available to help with questions ( 1-800-456-2255)

“California prohibits companies from offering copay assistance to patients three months after a generic becomes nationally available. For this reason, starting in mid-November the Biogen Copay Assistance Program will unfortunately no longer be available for TECFIDERA patients who reside in California or obtain their medication from a California pharmacy.


All impacted patients are being contacted to alert them of this change and, if requested by the patient, Biogen Support Services will help them investigate benefit options. Biogen remains committed to providing copay assistance for our other MS therapies, including another fumarate. We recommend patients speak to their healthcare provider to determine what is most appropriate for their situation, or contact Biogen Support Services at 1-800-456-2255.“

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